Chemotherapy, Radiation Therapy, Immunotherapy, and Bone Marrow Transplantation in Treating Patients With Neuroblastoma

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002634
First received: November 1, 1999
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, radiation therapy, immunotherapy, and bone marrow transplantation in treating patients with neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Biological: filgrastim
Biological: monoclonal antibody 3F8
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mesna
Drug: perfosfamide
Drug: vincristine sulfate
Procedure: autologous bone marrow transplantation
Procedure: in vitro-treated bone marrow transplantation
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Radiation: radioisotope therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: N7: EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 45
Study Start Date: February 1995
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Improve the complete remission rate and progression-free survival and reduce the relapse rate of patients with poor-risk neuroblastoma using intensive multimodality therapy: cyclophosphamide/doxorubicin/vincristine and cisplatin/etoposide, external-beam radiotherapy, and surgery (when feasible), followed by radioimmunotherapy with iodine I 131 labeled monoclonal antibody 3F8 followed by autologous bone marrow transplant and immunotherapy with unlabeled 3F8. II. Identify biologic and clinical prognostic factors that may guide future modifications in treatment approaches for this malignancy.

OUTLINE: Patients are stratified by prior therapy (yes vs no). Patients undergo surgery either at diagnosis or after at least 4 courses of chemotherapy, then possibly again after completion of chemotherapy. Patients receive cyclophosphamide IV over 6 hours on days 1-2, and doxorubicin IV and vincristine IV over 72 hours on days 1-3 for courses 1, 2, 4, and 6. Cisplatin IV over 1 hour on days 1-4 and vincristine IV over 2 hours on days 1-3 are administered as courses 3, 5, and 7. Courses are administered every 16-21 days. Autologous bone marrow is collected after 3 courses of chemotherapy providing marrow is negative for tumor cells. Patients undergo radiotherapy after the completion of chemotherapy. Radiotherapy is administered twice a day for 7 days. Patients then receive iodine I 131 labeled monoclonal antibody 3F8 (MOAB 3F8) on day -5 and again on days 1-5. Autologous bone marrow is reinfused on day 5 and filgrastim (G-CSF) is administered IV or subcutaneously beginning day 6. Patients who do not develop HAMA or an allergy to mouse proteins receive unlabeled MOAB 3F8 IV over 1.5 hours, 5 days a week for 2 weeks. Treatment repeats every 1-2 months for up to 4 courses. Patients are followed every month for 2 years, every 3 months for 1 year, then annually thereafter.

PROJECTED ACCRUAL: Up to 45 newly diagnosed patients will be accrued for this study within 5 years.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Neuroblastoma diagnosed in accordance with the International Neuroblastoma Staging system: Histologic confirmation at MSKCC OR Elevated urinary catecholamines plus tumor cells/clumps in bone marrow Stage IV or Stage II/III with more than 10 copies of N-myc proto-oncogene per tumor cell

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: Prior therapy allowed -Patient Characteristics-- Age: Over 1 year at diagnosis Performance status: Not specified Hematopoietic: Absolute neutrophil count at least 500/mm3 (except for cases of bone marrow infiltration by tumor) Platelet count at least 100,000/mm3 (except for cases of bone marrow infiltration by tumor) Hepatic: Not specified Renal: Not specified Other: No history of allergy to mouse proteins Human antimouse antibodies (HAMA) less than 1,000 U/ml (with prior exposure to murine antibodies)

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002634

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Cheung NV, Kushner BH, LaQuaglia MP, et al.: Anti-Gd2 monoclonal antibody (MOAB) 3F8-targeted therapy and dose intensity for children (1 yr of age) with stage 4 neuroblastoma (NB): key variables in sequential protocols at Memorial Sloan Kettering Cancer Center (MSKCC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-2305, 2000.

ClinicalTrials.gov Identifier: NCT00002634     History of Changes
Other Study ID Numbers: 94-011, CDR0000064084, MSKCC-FDR001041, NCI-V95-0622
Study First Received: November 1, 1999
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
localized resectable neuroblastoma
regional neuroblastoma
disseminated neuroblastoma
recurrent neuroblastoma
localized unresectable neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies
Antibodies, Monoclonal
Cyclophosphamide
Lenograstim
Liposomal doxorubicin
Cisplatin
Doxorubicin
Etoposide
Vincristine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014